Examination of Ventavis (Iloprost) Inhalation Behavior Using the I-Neb AAD System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 μg/mL (V10) to 20 μg/mL (V20) (VENTASWITCH)
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|ClinicalTrials.gov Identifier: NCT02826252|
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : March 15, 2017
|Condition or disease||Intervention/treatment|
|Hypertension, Pulmonary||Drug: Iloprost,(Ventavis, BAYQ6256) Device: I-Neb AAD system|
|Study Type :||Observational|
|Actual Enrollment :||64 participants|
|Official Title:||VENTASWITCH, Examination of Ventavis® (Iloprost) Inhalation Behavior Using the I-Neb® AAD® System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 μg/mL (V10) to 20 μg/mL (V20)|
|Actual Study Start Date :||September 15, 2016|
|Actual Primary Completion Date :||November 15, 2016|
|Actual Study Completion Date :||January 24, 2017|
The study will be conducted in patients who are enrolled in the German Ventavis patient support program Ventaplus.
Drug: Iloprost,(Ventavis, BAYQ6256)
Ventavis (Iloprost) nebulizer solution for inhalation as 10 μg/mL (V10) and 20 μg/mL (V20).
Device: I-Neb AAD system
Nebulizer, allows digital recording of inhalation data such as doses, inhalations per day and duration of inhalation (per day) etc.
- Number of inhalations on Iloprost 10 ug/mL and 20 ug/mL [ Time Frame: Up to 6 months ]
- Number of delivered doses (none/partial/full) on Iloprost 10 ug/mL and 20 ug/mL [ Time Frame: Up to 6 months ]
- Inhalation durations (min) per session on Iloprost 10 ug/mL and 20 ug/mL [ Time Frame: Up to 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826252
|Many locations, Germany|
|Study Director:||Bayer Study Director||Bayer|